- Keywords > chemical reference substances
- Keywords > Good Laboratory Practice (GLP)
- Keywords > Good Manufacturing Practices (GMP)
- Keywords > International Chemical Reference Substances (ICRS)
- Keywords > pharmacopoeial reference standards
- Keywords > quality assurance system
- Keywords > secondary chemical reference substance
- Keywords > tests, methods, and general requirements
- Keywords > WHO expert committee
(2007; 24 pages)
In 1975 the WHO Expert Committee on Specifications for Pharmaceutical Preparations recommended the “General guidelines for the establishment, maintenance and distribution of chemical reference substances”. At that time these general guidelines were aimed at fostering greater collaboration and harmonization among various national and regional authorities responsible for collections of chemical reference substances. This aim is still relevant. The guidelines were initially drawn up specifically for use by the WHO Collaborating Centre for Chemical Reference Substances in Sweden, which supplies International Chemical Reference Substances (ICRS).
These substances are primarily intended for use with pharmacopoeial monographs included in The International Pharmacopoeia.
It became evident that to ensure ready availability and cost-effectiveness, and in order to meet particular national or regional pharmacopoeial requirements, it was necessary to establish chemical reference substances external to the WHO Collaborating Centre for Chemical Reference Substances. Since the meticulous work of the WHO Collaborating Centre establishing the international collection would have to be duplicated in local or regional laboratories, guidelines were necessary to ensure the integrity of national or regional collections. The 1975 guidelines were reviewed and modified in 1982 and subsequently revised in 1999.
In 2004, the WHO Expert Committee on Specifications for Pharmaceutical Preparations recommended the development of more detailed guidelines on the establishment of secondary chemical reference substances. This additional guidance forms part B of the present revision and is intended to apply to secondary reference substances supplied as “official”, e.g. regional/ national standards, and not to the working standards of manufacturers or other laboratories. However, in principle, secondary reference standards prepared by manufacturers can be prepared as “working standards” using the same procedures.